Victoza LEADER Trial Top-Line Results Announced

Victoza LEADER trial of 9,000 adults with type 2 diabetes found that drug significantly reduced the risk of heart attack or stroke.

On March 4, 2016, Novo Nordisk announced the top-line results from the LEADER trial, which investigated the cardiovascular safety of Victoza® (liraglutide) over a period of up to 5 years in more than 9,000 adults with type 2 diabetes at high risk of major adverse cardiovascular events. The trial compared the addition of either Victoza® or placebo to standard of care and met the primary endpoint of showing non-inferiority as well as demonstrating superiority, with a statistically significant reduction in cardiovascular risk. The primary endpoint of the study was defined as the composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. The superior reduction of major adverse cardiovascular events demonstrated by Victoza® was derived from all three components of the endpoint.

The safety profile of Victoza® in LEADER was generally consistent with previous liraglutide clinical studies.

LEADER was a multicentre, international, randomised, double-blind, placebo-controlled trial investigating the long-term effects of Victoza® (1.2 and 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of cardiovascular events. The trial was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries that were followed for 3.5-5 years. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, explained that, “People with type 2 diabetes generally have a higher risk of experiencing major adverse cardiovascular events. That’s why we are very excited about the results from LEADER, which showed that Victoza®, in addition to helping people with type 2 diabetes control their blood sugar levels, also reduces their risk of major adverse cardiovascular events.” “LEADER is the largest and longest Novo Nordisk clinical trial to report to date, and we look forward to sharing the detailed results with the medical community and submitting the findings to the regulatory authorities.”

The detailed results are planned to be presented at the 76th Scientific Sessions of the American Diabetes Association in June 2016, which Diabetes In Control will be covering for our readers.